510(k) · Cleared
ClearedTempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oriental System Technology, Inc. · FLL Continuous Measurement Thermometer
Cleared on Feb 25, 2003 as substantially equivalent to K010235 (Oriental System Technology, Inc., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Feb 25, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010235 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK010235 Tempteller Infrared Ear Thermometer, Model CT-30/ CT-30DXOriental System Technology, Inc. · 2001
- This deviceK030299 Tempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DXOriental System Technology, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK101322 Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model…Joinsoon Electronics Mfg Co, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101322Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001Joinsoon Electronics Mfg Co, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010235 | Tempteller Infrared Ear Thermometer, Model CT-30/ CT-30DX | Oriental System Technology, Inc. | 2001 | — |
| 0 (this device) | K030299 | Tempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DX | Oriental System Technology, Inc. | 2003 | — |
| +1 | K101322 | Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001 | Joinsoon Electronics Mfg Co, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010235 | Tempteller Infrared Ear Thermometer, Model CT-30/ CT-30DXSummary page 1…s, Model CT-31/31DX/32/32DX 3. Information of the 510(k) Cleared Device (Predicate Device): TempTelledD Infrared Ear Thermometers, Model CT-30/30DX 51O(k) Number: K#010235 4. Device description: The OSTl TempTelledD Infrared Ear Thermometers, model CT-31/31DX/32/32DX, is an electronic thermomet… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101322 | Joinsoon Electronics MFG CO., LTD Infrared Ear Thermometer, Model TT-001 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K101322 (Joinsoon Electronics Mfg Co, Ltd., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The device is an electronic clinical thermometer using an infrared sensor to detect the
human body temperature from the auditory canal in the neonatal, pediatric and adult
Populations used in the home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030299 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030299: Tempteller Infared Ear Thermometers, Model CT-31/31DX/32/32DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030299
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026